BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 5691591 · Received June 1, 2016

    Report

    Report Number
    9673241-2016-00358
    Event Type
    Injury
    Date Received
    June 1, 2016
    Date of Event
    May 11, 2016
    Report Date
    May 11, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM (MODEL# M-4800-01 SERIAL# (B)(4)); STOCKERT 70 SYSTEM (MODEL# M-5463-01 SERIAL# (B)(4)); COOLFLOW PUMP (MODEL# M-5491-02 SERIAL# (B)(4)). (B)(4).

    Additional Manufacturer Narrative · 1

    A CORRECTION WAS MADE TO THE PRODUCT ANALYSIS CONCLUSION, CORRECT CONCLUSION IS AS FOLLOWS. IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BIDIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND THE TIP WAS FOUND CUT. FURTHER INFORMATION RECEIVED INDICATES THAT THE PRODUCT TIP WAS CUT OFF PRIOR TO SENDING THE CATHETER TO THE BWI FOR FAILURE ANALYSIS. DUE TO THIS CONDITION NO FURTHER ANALYSIS CAN BE PERFORMED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED; THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE OF THE TAMPONADE REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BIDIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND THE TIP WAS FOUND CUT. FURTHER INFORMATION RECEIVED INDICATES THAT THE PRODUCT TIP WAS CUT OFF PRIOR TO SENDING THE CATHETER TO THE BWI FOR FAILURE ANALYSIS. DUE TO THIS CONDITION NO FURTHER ANALYSIS CAN BE PERFORMED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED; THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BIDIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING ABLATION, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA TRANSTHORACIC ECHOCARDIOGRAM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME THIS COMPLAINT WAS REPORTED. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. THE PATIENT HAS FULLY RECOVERED. THERE WERE NO FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN DID NOT PROVIDE CAUSALITY OPINION. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A TZ MEDICAL NEEDLE. SHEATH USED WAS A PREFACE 8 FRENCH. GENERATOR WAS SET ON POWER CONTROL MODE WITH POWER CUT-OFF AT 50 WATTS AND TEMPERATURE CUT-OFF AT 45°C. POWER WAS NOT TITRATED DURING ABLATION. THERE IS NO INFORMATION REGARDING OVERALL ABLATION TIME OR LAST ABLATION CYCLE TIME AT THE SITE OF INJURY. IRRIGATED CATHETER FLOW WAS SET AT 30ML/MIN. THERE WERE NO ERROR MESSAGES OBSERVED ON BWI EQUIPMENT DURING THE PROCEDURE. PATIENT RECEIVED ANTICOAGULANTS DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIMES MAINTAINED AT MORE THAN 300 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345193 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-04-S 17431208M

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R